Comparison of Two Non-invasive Neuromodulation Techniques as Synergistic Therapy to Cognitive Stimulation in Amnestic Mild Cognitive Impairment (aMCI)

Recruiting now · Not applicable · Has a placebo group

Conditions studied: Mild Cognitive Impairment

In brief

This is a comparative, double-blind, randomized controlled clinical trial for people with Amnestic Mild Cognitive Impairment. The investigators will compare the effects of two non-invasive neuromodulation techniques (Repetitive Transcranial Magnetic Stimulation and Transcranial Direct Current Stimulation) combined with cognitive stimulation. These non-invasive neuromodulating techniques will be applied as a treatment alternative to be able to compare non-invasive techniques with cognitive stimulation CS alone, taking into account clinical and neuropsychological evaluations in addition to: 1) the known clinical risk factors (physical activity, comorbidities treatment, etc.) that allow the investigators to characterize the participants; 2) characterize the participants with genetic biomarkers using the APOE4, CR1, COMT, TREM2 and ABCA7 genotype; 3) document the biological effects related to neurogenesis from olfactory epithelial neural progenitor cells and solubles factors of serum; 4) use hippocampal volume, cortical thickness of the medial temporal cortex and parietal cortex by means of structural magnetic resonance imaging and the default mode network by means of functional magnetic resonance imaging at rest as a biomarker of response to treatment and 5) associate the response to treatment with changes in Motor Evoked Potential (MEP) amplitude and latency in order to generate a response-to-treatment biomarker with neuromodulators in Mild Cognitive Impairment (MCI) and changes in electroencephalogram.

Key facts

Study ID: NCT06467253
Run by: Instituto Nacional de Psiquiatría Dr. Ramón de la Fuente
People needed: 60
Starts: 2023-06-01
Expected to finish: 2027-06-15
Last updated by the study team: 2024-06-20

Who can join

Age: 55 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Being vaccinated against the SARS-COV2 virus.
Speak Spanish fluently.
Level of schooling greater than or equal to 6 years.
Amnestic mild cognitive impairment established by clinical examination performed by the treating physician (MoCA score: 19-25 points for probable aMCI) (based on the National Institute on Aging and Alzheimer's Association (NIA/AA) criteria, 2011).
Adequate visual and auditory acuity to perform neuropsychological tests and cognitive rehabilitation.
If receiving psychotropic drugs, having started the drugs at least 12 weeks before the start of the study, remaining at stable doses, or having suspended the drugs for at least 4 weeks before the study.
Be in good health without non-psychiatric medical diseases (uncontrolled systemic arterial hypertension, diabetes mellitus or dyslipidemia, infections, thyroid disease, vitamin deficiency) interfering with the study.
Willingness to participate in a study scheduled for 8 weeks and that participants can go to the Instituto Nacional De Psiquiatría for treatments, as well as scheduled evaluations.
An informant to respond to some of the assessment questionnaires throughout the study and who would stay with the participant for at least 10 h/week.

You may not qualify if…

Any neurological disease that raises suspicion of cognitive failure other than Alzheimer's disease, such as Parkinson's, multi-infarct dementia, Huntington's disease, hydrocephalus, brain tumor, progressive supranuclear palsy, seizure disorder, subdural hematoma, multiple sclerosis, history of trauma craniocerebral with loss of alertness.
Participants with a history of severe psychiatric disorders according to DSM-5 (bipolar disorder, schizophrenia, chronic depression) or with psychotic features, agitation, or behavioral problems in the last three months that could lead to difficulties in meeting the protocol.
History of psychoactive substance abuse and current alcohol consumption with a pattern of abuse or dependence in the last two years.
Participants with alterations in a conventional electroencephalogram (paroxysmal phenomena identified by a neurophysiologist).
Participants with pacemakers, intracranial metal objects, or history of brain surgery, aneurysm clips, artificial heart valves, ear implants, metal fragments, or foreign objects in the eyes, skin, or body.
Participation in the last 6 months in a clinical study that involved neuropsychological assessment.

Where it is running

Instituto Nacional de Psiquiatría Ramón de la Fuente Muñiz — Mexico City, Mexico (enrolling)

Full record on ClinicalTrials.gov

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